The National Institute for Health and Care Excellence (NICE) has issued its final appraisal decision (FAD) recommending reimbursement of lenvatinib for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine (RAI-R DTC).

This decision is part of a Multiple Technology Assessment resulting in the recommendation of both lenvatinib and sorafenib.

Thyroid cancer is the fastest growing cancer diagnosis in the UK and generally the prognosis is quite good, leading it to being mistakenly seen as a better cancer to have.

However, the aggressive form of DTC, in which patients are refractory to radioactive iodine therapy, carries a poorer prognosis with 66% of patients dying within five years of diagnosis.

There were approximately 3,388 people diagnosed with thyroid cancer in the UK in 20144.

It is also estimated that 5-15% of patients with differentiated thyroid cancer develop RAI-refractory DTC.

Lenvatinib is an oral, once-daily, selective tyrosine kinase inhibitor (TKI) which has a binding mode that appears to simultaneously inhibit the activities of numerous receptor proteins implicated in tumour growth and spread.

Its blockade of fibroblast growth factor receptor 1 (FGFR 1), which has division, growth and regulatory cellular functions, and is overexpressed in some cancers, together with blockade of VEGF (vascular endothelial growth factor) receptors which play a role in pathological angiogenesis, represents a dual blockade of tumour growth.

The European Medicines Agency (EMA) approval and subsequent NICE recommendation was based on the pivotal Phase 3 SELECT study that showed lenvatinib was associated with significant improvements in progression-free survival (PFS) in patients with progressive RAI-R DTC.

Median PFS with lenvatinib was 18.3 months compared to 3.6 months on placebo (HR 0.21; 99% CI 0.14–0.31, p<0.001).

In addition, the objective response rate was 64.8% versus 1.5% with placebo (p<0.001).

In this study, the most common treatment-related adverse events for lenvatinib were hypertension, diarrhoea, fatigue or asthenia, decreased appetite, decreased weight and nausea.

“This is fantastic news for the many patients in the UK who are diagnosed with advanced thyroid cancer. From the patient’s perspective, having treatment options is very important and with this recommendation NICE are providing exactly that,” commented Dr Jonathan Wadsley, Consultant Clinical Oncologist, Weston Park Hospital and Clinical Lead for Division 1 Yorkshire and Humber Clinical Research Network.

This positive NICE recommendation comes after the EMA approved lenvatinib for use almost three years ago in May 2015, and the Scottish Medicines Consortium (SMC) approved it for reimbursement in October 2016. This was followed by the All Wales Medicines Strategy Group’s approval in October 2017.

“RAI-R DTC can impact severely on a patient’s life, as well as on the lives of their loved ones,” said Kate Farnell MBE, CEO of the Butterfly Thyroid Cancer Trust. “With limited options available for patients with this type of thyroid cancer, we very much welcome this decision from NICE that demonstrates that these patients are no longer forgotten.”

Source: Tonic Communications